1. No category

Daniel O`Day
COO Roche Pharma
Boston, March 2015
This presentation contains certain forward-looking statements. These forward-looking
statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’,
‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among
other things, strategy, goals, plans or intentions. Various factors may cause actual results to
differ materially in the future from those reflected in forward-looking statements contained in
this presentation, among others:
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pricing and product initiatives of competitors;
legislative and regulatory developments and economic conditions;
delay or inability in obtaining regulatory approvals or bringing products to market;
fluctuations in currency exchange rates and general financial market conditions;
uncertainties in the discovery, development or marketing of new products or new uses of existing
products, including without limitation negative results of clinical trials or research projects, unexpected
side-effects of pipeline or marketed products;
increased government pricing pressures;
interruptions in production;
loss of or inability to obtain adequate protection for intellectual property rights;
litigation;
loss of key executives or other employees; and
adverse publicity and news coverage.
Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to
mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily
match or exceed the historical published earnings or earnings per share of Roche.
For marketed products discussed in this presentation, please see full prescribing information on our website
www.roche.com
All mentioned trademarks are legally protected.
3
Performance update
Foundation Medicine acquisition
Pharma pipeline update
Outlook
4
2014: Targets achieved
Targets for 2014
Group sales
Low to mid-single digit growth1
FY 2014
+5%

+5%
Core EPS
Ahead of sales growth1
+7%

excl. one-time
US Pharma fee2
Dividend
Further increase dividend3
CHF 8.00
+3%

At constant exchange rates
One-time double charge of CHF 202m for the US Branded Prescription Drug fee in 2014, following final regulations issued by the US
Internal Revenue Service which advanced the timing of recording the liability
3 2014 dividend as proposed by the Board of Directors
1
2
5
2014: Highlights
Growth
• Group sales +5%1 driven by HER2 franchise (+20%1), Avastin (+6%1), Actemra (+23%1) and
Professional Diagnostics (+8%1)
• Outperformance in all major regions: +6%1 in US, Japan & International; +3%1 in Europe
Innovation
• Three Breakthrough Therapy Designations: Anti-PDL1, Esbriet and Lucentis
• Three Fast Track Designations: Lampalizumab, cobimetinib and LptD (antibiotic)
• Cancer immunotherapy: New PD-L1 data in bladder, TNBC, renal. Six new agents entered clinic
• Phase 3 starts: Lampalizumab, etrolizumab, alectinib, venetoclax and Kadcyla adjuvant
• Launched next generation molecular diagnostics platform (cobas 6800/8800)
M&A
• InterMune: Acquisition completed
• Foundation Medicine: Collaboration announced
1 CER=Constant
Exchange Rates
6
2014: Continued sales growth for 4 years
10%
8%
8%
7%
6%
6%
6%
5%
5%
4%
4%
4%
2%
0%
6%
6%
4%
4%
2%
0% 0%
Q1
11
Q2
11
1%
Q3
11
Q4
11
Q1
12
All growth rates at Constant Exchange Rates (CER)
Q2
12
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
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2014: Both Divisions with sales growth in all
regions
CHFbn
20
+6%
18
+4%
16
+3%
14
+6%
12
+2%
Diagnostics
+13%
10
+6%
8
6
+6%
4
0%
2
+7%
+2%
Pharma
+3%
0
Japan
International
All growth rates at Constant Exchange Rates (CER)
Europe
US
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2014: Core operating profit and margin
Margin at high levels
44.0%
37.7%
38.3%
CHFm
37.2% (-0.1%p2)
-0.5 %p1
(-1.1 %p)
1
+3 %
(-1 %)
17,160 17,904 17,636
44.4%
43.6% (+0.3%p2)
-0.2 %p1
(-0.8 %p)
+4 %1
(-1 %)
15,488 16,108 16,001
% of sales
21.3%
20.8%
19.5%
-0.9 %p1
(-1.3 %p)
+2 %1
(-4 %)
2012
2013
Roche Group
1 CER=Constant
2 At
2,187 2,177 2,096
2014
Pharma Division
Exchange Rates
CER excluding one-time double charge for the US Branded Prescription Drug fee in 2014
Diagnostics Division
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2014: Dividend and payout ratio further increased
CHF
Dividend payout ratio (%)
10,00
55,3
9,00
8,00
51,6
48,6
44,8
2014 payout ratio: 56.0%
7,00
6,00
5,00
31,9
54,7
54,5
56.0
8.00
38,8
34,5
4,00
3,00
2,00
1,00
0,00
1990
1992
1994
1996
1998
2000
2002
2004
2006
2008
2010
2012
Payout ratio calculated as dividend per share divided by core earnings per share (diluted); 2014 dividend as proposed by the Board of
1 compound annual growth rate
Directors;
Note: For 1995, a special dividend was paid out to mark F. Hoffmann-La Roche’s 100th anniversary in 1996
2014
10
Performance update
Foundation Medicine acquisition
Pharma pipeline update
Outlook
11
Foundation Medicine: Overview
Leader in oncology molecular information
Company facts
• Founded 2010 in Cambridge, MA, USA
FMI’s solution: A molecular
information platform
• Primarily VC-funded until IPO in 2013
• Core proprietary molecular information
platform
• Two leading solutions for comprehensive
genomic profiling of cancers
– FoundationOne: solid tumors
– FoundationOne Heme: hematologic
cancers and sarcomas
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FMI: Clinical business
Molecular information and services
Physicians send
samples to FMI
Sample
Generate Data
Interpret Data
Sample preparation
Clinical Knowledgebase
Genomic sequencing
Contains sequencing data
from patients and literature*
Interactive patient report is sent to the oncologist
Report contains treatment options including FDA-approved
targeted therapies and novel treatments in development
Illustrative
*Also starting to contain outcomes data
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Patient journey – FMI’s role
Molecular information platform
Diagnosis
Comprehensive
assessment of
disease
Oncologist decision
Monitoring
• Established treatment
• Experimental treatment/
trial
• Sustained
response/cure?
• Progression?
FMI offering:
Portal for Physicians
1 Comprehensive tests* 2 Standardized knowledgebase 3 Molecular information
*Next Generation sequencing
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1
Comprehensive tests
Tissue limited and multiple modalities required
Today
Single assays, “tissue is the issue”
Example: Lung Cancer
Future
Multiplex assays and Monitoring
Example: Lung Cancer
Comprehensive tumor analysis…
Multiple modalities required including:
Lung Biopsy
8-10 slides
DNA & RNA
sequencing
Enough tissue for
only 2-3 individual
tests
8-10 slides
Protein expression
– Multiplex IHC
…and continuous monitoring
Produces a single snapshot
Blood
Imaging
Illustrative
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2
Standardized knowledgebase
Enables comparability of results both in R&D
and in the clinic
In R&D
Comparability of results essential
• Comprehensive genomic profiling leads
to better insights across programs:
“bench to bedside to bench”
Early R&D Data
Clinical Trial Data
• Translates to the clinic as well:
– Same assay in R&D and the clinic
improves confidence in results
– Results comparable across centers/
hospitals
Produces a powerful
knowledgebase and enables
faster insight generation
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3
Molecular information platform
Essential to extract insights out of large volumes of data
Value for Physicians
Interactive, easy to read, and meaningful report
Value for Pharma customers
Support in interpreting data generated via
clinical trials – also prospectively for trial
design and patient screening
Foundation Medicine differentiated by their ability to extract insights from their
knowledgebases and their partnerships with major medical centers and providers
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Summary of FMI fit to Roche
Meets urgent current needs and adds key capabilities
FMI offering
Value for Roche
Comprehensive DNA and RNA
sequencing tests that complement
Roche capabilities
Standardized clinical trial data
captured in a knowledgebase
Data analysis to provide R&D insights
Potential for faster uptake of new
medicines and combinations
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Roche and FMI can innovate together
Immunotherapy and continuous monitoring key
areas for collaboration
Future
Multiplex assays and Monitoring
Example: Lung Cancer
Comprehensive tumor analysis…
Multiple modalities required including:
DNA & RNA
sequencing
Protein expression
– Multiplex IHC
8-10 slides
Key innovations that Roche and FMI
can develop together:
1 RNA-based Immunotherapy test
2 Continuous monitoring of tumor
specific molecular alterations in blood
…and continuous monitoring
Blood
Imaging
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Performance update
Foundation Medicine acquisition
Pharma pipeline update
Outlook
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Roche: A pipeline of differentiated products
Oncology
Launched
Phase III
Phase II
Avastin
Rituxan/MabThera
Herceptin
Xeloda
Tarceva
Zelboraf
Erivedge
Perjeta
Kadcyla
Gazyva/Gazyvaro
Oncology
Immunology/
Ophthalmology
Esbriet
Pulmozyme
Neuroscience
Ophthalmology
Immunology
Xolair
Actemra/RoActemra
Rituxan/MabThera RA
Lucentis
pictilisib1
taselisib1
anti-PDL1
venetoclax (Bcl2i)
cobimetinib4
alectinib
lampalizumab3
ocrelizumab
gantenerumab
10 NMEs + 9 AIs
3 AIs
6 NMEs
lebrikizumab
etrolizumab2
Neuroscience
Phase III decision pending; 2 FPI in 1H 2014; 3 FPI in 2H 2014; 4 Filed in combination with Zelboraf in metastatic melanoma
AI = Additional Indication; NME = New Molecular Entity
1
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HER2 franchise expected to grow further
Biosimilars delayed to 2017
Est. Biosimilars
launch (EU)
2nd line
mBC
Xeloda + lapatinib
1st line
mBC
Herceptin
+ chemo
Adjuvant
BC
Herceptin +
chemo
Kadcyla (EMILIA)
Herceptin & Perjeta + chemo (CLEOPATRA)
Herceptin sc + chemo
(HannaH)
Neoadjuvant Herceptin + chemo
BC
(NOAH)1
2011
2012
Established standard of care
Herceptin & Perjeta
+ chemo (APHINITY)
Herceptin & Perjeta + chemo
(Neosphere, Tryphaena)2
2013
2014
2015
Kadcyla & Perjeta
+ chemo (KRISTINE)
2016
2017
New standard of care
2018
Kadcyla (KATHERINE)
Kadcyla & Perjeta
(KAITLIN)
2019
2020
Potential new standard of care
Key priorities in 2015
• Strengthen PERJETA as standard of care in 1L mBC & neoadjuvant, Kadcyla in 2L
• Secure durable conversion from Herceptin IV to SC
Clinical data in 2015
• PERJETA 2L PHEREXA final PFS & interim OS data expected Q3 15
• Release of the NEOSPHERE final PFS/DFS data at ASCO
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Hematology franchise
Extensive late stage clinical trial program
Biosimilars delayed to 2017
Compound
Combination*
Indication
P1
P2
Gazyva
Mono GREEN
CLL
Gazyva
Mono GOYA
aNHL
Gazyva
Mono GADOLIN
iNHL
Gazyva
Mono GALLIUM
1L FL




Gazyva
+PDL1
R/R FL
Gazyva
+PDL1
aNHL
venetoclax**
+Rituxan MURANO
R/R CLL
venetoclax
+Gazyva CLL14
CLL
venetoclax
Mono
R/R CLL 17p
venetoclax
+Rituxan
R/R FL
venetoclax
+Rituxan/Gazyva
1L aNHL
venetoclax
+Rituxan
R/R NHL
venetoclax
Mono
R/R MM
venetoclax
Mono
AML
polatuzumab
+Rituxan/Gazyva
NHL
polatuzumab
+Gazyva
R/R FL
polatuzumab
+Gazyva
aNHL

















P3




 
 





* Combination(s) with branded Roche compounds
** venetoclax in collaboration with AbbVie
venetoclax (Bcl2 inhibitor); polatuzumab vedotin (CD79b ADC)
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2014 Roche cancer immunotherapy:
Six NMEs moved into the clinic
T cell Trafficking
 New in 2014
Priming & activation
 Anti-CEA-IL2v
 Anti-OX40
NME (Anti-ctyokine)
T cell infiltration
Anti-CD27*
Anti VEGF: Avastin
Antigen presentation
 Anti-CD40
IMA942 vaccine*
Cancer T cell recognition
(Immatics)
 Anti-CEA-CD3
Anti-HER2-TDB
Antigen/T cell bispecific Mabs
ImmTAC* (Immunocore)
T cell killing
Clinical development
Preclinical development
Established therapies
*
Partnered projects (external)
Chen and Mellman. Immunity 2013
Antigen release
Targeted therapies:
Tarceva, cobimetinib,
Zelboraf, Gazyva




Anti-PD-L1
Anti-CSF-1R
Anti-CEA-IL2v
Anti-OX40
IDO inhibitor (NewLink Genetics)
NME (undisclosed)
IDO inhibitor* (Incyte)
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Cancer immunotherapy program growing strongly
Compound
Combination
Indication
PDL1
Mono
+Tarceva
Lung
PDL1
Mono
Bladder
PDL1
PDL1

Mono
+Avastin
+Zelboraf
+Zelboraf+cobimetinib
Renal
Melanoma
Mono
+Avastin
+cobimetinib
+ipilimumab
+IFN alfa-2b
+CD40
+OX40
+CSF-R1
+CEA IL2v
Solid tumors
PDL1
+Avastin+FOLFOX
Colorectal
PDL1
Mono
+Gazyva
Hematology
PDL1



 Mono
PDL1
Triple negative breast cancer
CSF-1R
Mono
+CD40
Solid tumors
CEA IL-2v
Mono
Solid tumors
OX40
Mono
Solid tumors
 Mono
 Mono
Solid tumors
CEA CD3
IDO

Study ongoing
Solid tumors

Study imminent
 Additions since Q3
Ph 1
Ph 2
Ph 3
































Status as at January 2015
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Roche cancer immunotherapy
Pipeline as of 2014 year end…
Phase I
Anti-PDL1+Tarceva
NSCLC
Anti-PDL1+Zelboraf
Melanoma
Anti-PDL1
Solid tumors
Anti-PDL1+Avastin
Solid tumors
Anti-PDL1+cobimetinib
Solid tumors
Anti-PDL1+ipilimumab
Solid tumors
Anti-PDL1+IFN-alfa
Solid tumors
Anti-PDL1+ CD40
Solid tumors
PDL1+Avastin+FOLFOX
CRC
Anti-PDL1 + Gazyva
Blood cancer
Anti-PDL1
TNBC
Anti-CSF1R
Solid tumors
Anti-CEA IL-2v
Solid tumors
Status as at December 2014
Phase II
Anti-PDL1
NSCLC (Dx+)
Anti-PDL1
NSCLC 2/3L
Anti-PDL1+Avastin
Renal 1L
Anti-PDL1
Bladder 1/2L
Anti-OX40
Solid tumors
CEA CD3
Solid tumors
IDO
Solid tumors
Phase III
Anti-PDL1
NSCLC 2/3 L
Anti-PDL1 trials
NMEs monotherapy
Immune doublets
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Roche cancer immunotherapy
…and additional trials already decided upon
Phase I
Anti-PDL1+Tarceva
NSCLC
Anti-PDL1+Zelboraf
Melanoma
Anti-PDL1
Solid tumors
Anti-PDL1+Avastin
Solid tumors
Anti-PDL1+cobimetinib
Solid tumors
Anti-PDL1+ipilimumab
Solid tumors
Anti-PDL1+IFN-alfa
Solid tumors
Anti-PDL1+ CD40
Solid tumors
PDL1+Avastin+FOLFOX
CRC
Anti-PDL1 + Gazyva
Blood cancer
Anti-PDL1
TNBC
Anti-CSF1R
Solid tumors
Anti-CEA IL-2v
Solid tumors
Status as at January 28, 2015
Phase II
Anti-OX40
Solid tumors
CEA CD3
Solid tumors
IDO
Solid tumors
Anti-PDL1 + OX40**
Solid tumors
Anti-PDL1 + CSF1R**
Solid tumors
Anti-PDL1 + CEA-IL2v**
Solid tumors
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1
NSCLC (Dx+)
Anti-PDL1
NSCLC 2/3L
Anti-PDL1+Avastin
Renal 1L
Anti-PDL1
Bladder 1/2L
Anti-PDL1 trials
NMEs monotherapy
Phase III
Anti-PDL1
NSCLC 2/3 L
Anti-PDL1**
Bladder 2L
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Anti-PDL1**
tba
Immune doublets
2015 readout expected
**
Study start in 2015
27
ACE 910 in Hemophilia A
FVIIIa
NON-INHIBITOR
A novel FVIIIa mimetic bispecific antibody
INHIBITOR
ACE 910
Kitazawa, Shima, Yoshioka, Hattori . Nature Medicine 2012;18(10):1570,
Sampei, et al. PLoS One 2013;8(2):e57479, Muto, Shima, Hattori . J Thromb
Haemost 2014;12:206
On-demand treatment
1-3 times/bleeding event, IV
Prophylaxis
3 times/week, IV
Inhibiting Factor VIII antibodies in 20-33% of the patients
Immune Tolerance Induction
70-80 % success rate
limitation due to very high cost and heavy burden for
patients
On-demand treatment with
bypassing agents
2-3h intervals, IV
Prophylaxis with bypassing
agents
Every other day, IV
Mode of action
Targeted product profile
Novel approach promoting FX activation
and acceleration of coagulation
• Less frequent dosing
• Subcutaneous
• Avoid induction of inhibiting antibodies
In collaboration with Chugai
28
Performance update
Foundation Medicine acquisition
Pharma pipeline update
Outlook
29
2015 milestones
Launch new products
Expand cancer
immunotherapy
Renew CD20 franchise
Esbriet: US and EU
Cobimetinib + Zelboraf: US and EU
PD-L1: Bladder, Lung, Renal, Triple Negative BC
NMEs: OX40, CD40, CEA-IL2, CSF1R, IDO, CEA-CD3
Gazyva (aggressive NHL)*
Entry into Hemophilia
ACE910: Start of pivotal trials
Entry into Multiple Sclerosis
Ocrelizumab: Phase 3 readout
Diagnostics
* Event-driven (interim analysis)
Rollout of key platforms (cobas 6800 / 8800)
30
2015 outlook
1 At
2
Group sales growth1
Low to mid-single digit
Core EPS growth1
Ahead of sales growth2
Dividend outlook
Further increase dividend in Swiss francs
constant exchange rates
Excluding sale of filgrastim rights in 2014
31
Doing now what patients need next